MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 HIGH WALL E1 LINER 32MM B; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2015

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Country of origin: (b)(6).This report is being submitted late as it has been identified in remediation.Complaint sample was evaluated and the reported event was confirmed.The part passed inspection of the outer profile with the exception of some deformed areas where the liners are damaged.This damage likely occurred during the procedure.T product likely left biomet control conforming.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported during an initial total hip arthroplasty, the surgeon pressed the high wall liner by hand in the g7 cup.There was no soft tissue between, no screws and impacted the liner with the g7 ball impactor.Correct surgical technique was used.The liner appeared to lock in, but during the trial reduction, the liner disassembled from the cup.To complete the procedure a neutral liner and the same cup were used.The cup did not have to be removed as it was well fixed.There was a delay in procedure, but less than 30 minutes.No adverse event occurred as a result of this event.

• Brand Name: G7 HIGH WALL E1 LINER 32MM B
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6957643
• MDR Text Key: 89618818
• Report Number: 0001825034-2017-09057
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PK121874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 010000924
• Device Lot Number: 3480321
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2015
• Initial Date FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1